- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07857681
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
Visão geral do estudo
Status
Condições
Descrição detalhada
PRIMARY OBJECTIVES:
I. Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Exclusion Criteria:
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
- Participants who cannot receive text messaging or have access to smart device
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Cohort II (standard Quitline materials)
Participants receive standard Quitline materials in the mail on study. |
Receive standard Quitline materials
Outros nomes:
|
|
Experimental: Group I (educational material by mail)
Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Outros nomes:
Receive an educational flyer by mail
Outros nomes:
Receive access to a website Receive access to a QR code
Outros nomes:
|
|
Experimental: Group III (educational messaging by text)
Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Outros nomes:
Receive access to a website Receive access to a QR code
Outros nomes:
Receive an educational message by text
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Engagement with quick response (QR) code scans
Prazo: Up to 12 months
|
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website Utilization
Prazo: Up to 12 months
|
total number of visits, unique visitors, |
Up to 12 months
|
|
Interactions with online resources
Prazo: Up to 12 months
|
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website utilization
Prazo: Up to 12 months
|
Duration of sessions |
Up to 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of website interactions from the mailed flyer
Prazo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the mailed flyer
Prazo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of website interactions from the text message
Prazo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the text message
Prazo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Duration spent on the cessation website
Prazo: Up to 12 months
|
Will assess depth of engagement. |
Up to 12 months
|
|
Number of pages or resources accessed on the website
Prazo: Up to 12 months
|
Will evaluate participant utilization of the content. |
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah Pearson-Collins, Roswell Park Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Técnicas de investigação
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Serviços de Saúde Infantil
- Serviços de Saúde Comunitária
- Serviços de Saúde Preventiva
- Fatores socioeconômicos
- Características da população
- Materiais fabricados
- Tecnologia, indústria e agricultura
- Métodos
- Intervenção precoce, educacional
- Status educacional
- Dispositivos para fumantes
Outros números de identificação do estudo
- I-4464925
- NCI-2025-03221 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- I-4464925 (Outro identificador: Roswell Park Cancer Institute)
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